Administrative agencies, world wide, have promulgated rules and regulations for the manufacture of pharmaceutical and biotechnology products. These rules and regulations, inter alia, stipulate that Pharmaceutical and Biotech companies are required to “validate” their products, processes, and equipment used in the manufacture of a drug (or other related product—e.g. raw materials) in order to obtain a manufacturing license. In short, validation is a process that evidences to the administrative agencies that the pharma/biotech (i.e. the pharma/biotech companies seeking manufacturing licenses) companies' facilities and equipment consistently produce products that meet predetermined quality and safety standards.
Validation efforts are often arduous and expensive. In a typical validation life cycle, the equipment, facility, and/or process is first identified. The equipment, facility, and/or process is then described in accordance with validation guidelines to generate a validation protocol. The validation protocol, inter alia, describes the equipment, facility, and/or process that is being validated along with one or more tests that will be applied to the equipment, facility, and/or process that will ensure that the equipment, facility, and/or process satisfy predetermined quality and safety standards. The level of detail required in a typical validation protocol can be mind-numbing. It is not hard to imagine that such efforts are both time and labor intensive. Moreover, there is additional significant time and labor expended in managing the workflow between validation personnel and project personnel (e.g. project managers, engineers, etc.) in the validation life cycle. Specifically, validation personnel must constantly communicate with project personnel to ensure that the validation protocols being prepared and executed are accurate and complete. The validation industry as a whole are late adopters of technology, however, often relying on traditional and conventional communication media, such as person-to-person conferences, teleconferences, postal mail, facsimile, and for the lofty, e-mail which often contributes to delays in completing validation and contributes to the loss of data between cooperating parties of a validation effort.
Currently, pharma/biotech companies have few options when performing validation. They may undertake the expensive task of maintaining an in-house validation department having personnel dedicated to performing the validation life cycle. Alternatively, many companies may outsource validation efforts to validation consulting companies. The validation consulting companies have validation personnel (e.g. validation engineers, validation project managers, etc.) that maintain expertise in performing validation for pharma/bio-tech companies. Although, cheaper than maintaining a full validation department, outsourcing validation efforts is not inexpensive. Knowing the critical nature of validation, validation consulting companies also are not shy in charging a premium to perform validation services. However, often times, the services provided by validation personnel are not unique. That is, validation consultants are often guilty of reworking existing validation protocols to meet new project specifications and leveraging boiler-plate validation protocols. Such practice results in significant margins for validation consultants and significant expense to pharma/bio-tech companies.
Some efforts have been made to reduce the costs of validation life cycle by improving workflow management. Included, is the development of workflow management software that helps pharma/bio-tech companies better track and monitor validation efforts. Such software is typically geared towards managerial efforts and does not contribute to the creation and/or deployment of validation protocols; validation protocols that are at the heart of the validation life cycle. Even with the deployment of such workflow management software, the validation life cycle can still be extremely burdensome as valuable and expensive time and labor is dedicated to the creation and deployment of validation protocols. Further, current workflow management software, although helpful in monitoring validation workflow, does not allow for centralized storage and access of the validation protocols. Moreover, current workflow management software does not facilitate communication between the parties of the validation life cycle (e.g. pharma/bio-tech project personnel and management, validation personnel, etc.); vital communication that may be critical to the efficient and successful creation and deployment of validation protocols.
In addition to the development of workflow management software, there have been some attempts to incorporate some of the validation reporting requirements in project management software. Such software allows pharma/bio-tech companies to integrate the results of validation protocol deployment into project plans and reports. However, akin to the workflow management software, the project management software does not provide functionality that assists companies to create, manage, store, track, and test the all important validation protocols.
From the foregoing it can be appreciated that there exists a need for comprehensive systems and methods that overcome the shortcomings of existing practices.